U.S. federal health officials say results from a U.S. trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information."
The Data and Safety Monitoring Board said in a statement that it was concerned that AstraZeneca may have provided an incomplete view of the efficacy data.
"The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data," the agency said in a statement. "We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible."
In a statement released just before 8 a.m. ET on Tuesday, AstraZeneca promised to release more data on the study within the coming days.
"We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis," the company said in a press release. "We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours."
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that could help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S.
The U.S. study was conducted with more than 30,000 test subjects, and AstraZeneca's findings said that its vaccine was 79% effective in preventing the virus, including in people older than 65. The company also said that the study found the vaccine prevents all severe cases of the virus and that no subjects died.
At a White House COVID-19 response team briefing on Tuesday, Dr. Anthony Fauci, the nation's top expert on infectious diseases, said that the report was an encouraging sign, but added that the FDA still needed to conduct a rigorous review of the vaccine — as it has for all other COVID-19 vaccines.
"[The FDA] will put a great deal of scrutiny in every aspect of this data," Fauci said.
Several European countries briefly paused the use of the AstraZeneca vaccine last week after reports surfaced that a handful of the 17 million Europeans who have taken the vaccine reported unusual blood clotting. The EU's top medical agency has since said the vaccine was not the cause for the clotting, and the company's U.S. study found no adverse side effects to the drug.